Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00872677

Purpose

RATIONALE: A culturally sensitive weight loss program for obese African American breast cancer survivors may be more effective than a standard weight loss program in helping women lose weight.

PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to see how well it works in African American women who are breast cancer survivors.

Condition	Intervention
Breast Cancer Obesity Weight Changes	Behavioral: behavioral dietary intervention Behavioral: exercise intervention Other: counseling intervention Other: educational intervention Procedure: meditation therapy Procedure: spiritual therapy Procedure: stress management therapy

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control
Official Title:	A Culturally-Tailored Weight Loss Program

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Obesity Weight Control

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Weight change [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2004
Estimated Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To develop a weight loss intervention for obese African American women who are breast cancer survivors.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 intervention groups.

Group 1: Participants receive traditional individual dietary and exercise counseling in combination with the Weight Watchers weight loss program for 18 months.
Group 2: Participants receive individual dietary and exercise counseling in combination with the Weight Watchers weight loss program as in group 1. They also receive spiritual counseling that incorporates meditation, readings, and the recording of thoughts into a long-term weight management program. The program addresses coping with stress, setting priorities, dealing with emotional issues that trigger old behavior patterns, and developing accountability for following desired diet and exercise patterns.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer within the past 5 years
- Stage I-IIIA disease
- No recurrence of cancer
Identified as African American
Body Mass Index 30-40
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
Stable body weight
Not currently following a special diet
No uncontrolled congestive heart failure, untreated hypertension, disabling osteoarthritis, drug or alcohol abuse, or psychiatric conditions that may interfere with counseling

PRIOR CONCURRENT THERAPY:

More than 3 months since prior chemotherapy or radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872677

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Michael S. Simon, MD, MPH

Barbara Ann Karmanos Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000612147, NCCAM-013003B3E
Study First Received:	March 28, 2009
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00872677 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

weight changes
obesity
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:

Obesity
Skin Diseases
Breast Neoplasms
Overweight
Body Weight
Signs and Symptoms
Neoplasms

Neoplasms by Site
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009